Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information

Obeticholic acid

EU orphan designation number: EU/3/13/1228   
Active ingredient: Obeticholic acid
Indication: Treatment of primary sclerosing cholangitis
Sponsor: Intercept Pharma Ltd
2 Pancras Square, London N1C 4AG, United Kingdom

   Public summary of scientific opinion    

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
21/01/2014 Orphan designation EMA/OD/136/13 (2014)298 of 16/01/2014
20/06/2016 Transfer of orphan designation EMA/OD/136/13/T/01 (2016)3843 of 16/06/2016